The U.S. Food and Drug Administration has granted marketing authorization for the first home syphilis test.
The over-the-counter First To Know Syphilis Test, manufactured by NOWDiagnostics in Arkansas, detects antibodies to Treponema pallidum (syphilis), according to a news release.
The test, which does not require a prescription, takes about 15 minutes to administer using just a drop of blood, “like a finger prick,” the company said.
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The results will be positive for those who have a current syphilis infection, as well as for those who have already been diagnosed, even if they were successfully treated.
However, test results alone are not sufficient to diagnose syphilis and should be followed by additional testing by a provider to confirm the diagnosis, according to the FDA.
The first test for syphilis, shown here, uses a blood sample to detect the infection. (NOW x)
A clinical study of 1,270 people found the product to be “easy to use,” a NOWDiagnostics news release noted.
The results of the study showed that the test correctly identified 99.5% of negative results and 93.4% of positive diagnoses.
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“This advancement in diagnostic testing allows people to take control of their health from the privacy of their own home, playing a critical role in early detection and treatment and ultimately helping to slow the spread of syphilis and protect public health.”
“This is a major breakthrough and its accuracy has been proven,” one doctor said. (NOW x)
Efforts to stop the rise
There has been a significant increase in syphilis cases in the U.S. in recent years.
Cases increased by 80% between 2018 and 2022, according to data from the Centers for Disease Control and Prevention (CDC).
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In 2022, more than 3,700 cases of congenital syphilis were reported among newborns, the agency said.
Earlier this year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to help combat the rising numbers.
The results of the study showed that the test correctly identified 99.5% of negative results and 93.4% of positive diagnoses. (iStock; NOWDx)
In addition to the task force, the FDA said that the authorization of this new home test will help “reverse the recent dramatic increase in STIs in the United States.”
“If left untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis,” the FDA wrote in the news release.
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“When transmitted during pregnancy, it can cause miscarriages, lifelong medical problems and infant death.”
“When transmitted during pregnancy, [syphilis] “It can cause miscarriages, lifelong medical problems and infant death.”
The program has been shown to “significantly reduce clinical infection,” said New York-based Siegel.
Siegel called the new syphilis test “especially important” because “the earlier the exposure and diagnosis of syphilis, the better.”
The FDA said the authorization of the new home test will help “reverse the recent dramatic rise in STIs in the United States.” (iStock)
Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, wrote in a statement that advances in STI testing can “give patients more information about their health from the privacy of their own home.”
“Access to home testing can help increase initial detection of syphilis, even in people who may be reluctant to consult their health care provider for possible exposure to a sexually transmitted infection,” she said.
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This may lead to increased laboratory testing to confirm the diagnosis, Tarver added, which can increase treatment and help slow the spread.
The FDA confirmed that false negative results can occur, which can cause delays in treatment and further spread of infection. (iStock)
Saphier added that as syphilis cases rise, it is “disappointing to see so many advanced cases of an otherwise treatable disease.”
“While prevention is always the best method, early detection and therapeutic intervention are essential not only to achieve the best health outcome, but also to reduce the overall cost burden on society, because advanced disease and disability are costly,” he said.
Potential Limitations
Saphier shared some concerns about using home tests to detect diseases, as they “often have lower accuracy than standardized laboratory tests.”
“This can lead to false negative results as a person who would otherwise need treatment may not seek it,” he explained.
“If someone is [at] “If they are at high risk of exposure to syphilis or have symptoms, they should avoid home testing and talk to their doctor.”
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The FDA confirmed that false negative results can occur, which could cause delays in treatment.
Symptoms of congenital syphilis include skin sores and rashes, fever, jaundice, sneezing or runny nose, and inflammation of the spleen and liver, according to the Mayo Clinic. (iStock)
“Test results alone should not be used to start, stop, or change any treatment without the advice of a healthcare provider,” the FDA wrote in the news release.
“If someone is [at] “If they are at high risk of exposure to syphilis or have symptoms, they should avoid home testing and talk to their doctor.”
“In addition, individuals who use this test and who have been recently exposed to syphilis should seek medical attention for treatment and evaluation, regardless of the results of this test.”
Symptoms of congenital syphilis include skin sores and rashes, fever, jaundice, sneezing or runny nose, and swelling of the spleen and liver, according to the Mayo Clinic website.
If left untreated, later symptoms can include hearing loss, dental problems and “saddle nose,” a condition in which the bridge of the nose collapses.
